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NeuroBo Pharmaceuticals has announced its plans to initiate a phase III trial to evaluate the efficacy of its lead drug, NB-01, in diabetic neuropathic pain in early second quarter of this year.

Image: NeuroBo is set to start clinical trial of NB-01 in adult patients with diabetic neuropathic pain. Photo: courtesy of yodiyim / FreeDigitalPhotos.net.

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The company’s drug pipeline also includes an IND-ready therapeutic candidate for Alzheimer’s disease. These two candidates are based on extensive clinical and/or preclinical R&D originally conducted by Dong-A ST, a major Korean pharmaceutical company.

NeuroBo Pharmaceuticals president and CEO John Brooks III said: “The planned initiation of our Phase III study for NB-01 marks a crucial milestone not just for NeuroBo, but for the study of neuropathic pain broadly.

“Neuropathic pain affects more than 80 million patients today and our drug has tremendous potential to impact patient care with a safe and efficacious oral therapy.”

B-01 has previously shown successful Phase II results in treating diabetic neuropathic pain demonstrating a high efficacy in pain reduction with minimal to no side effects versus placebo – a highly desirable product profile compared to existing approved drugs in the market.

The Phase III study is a double-blind, placebo controlled, 12-week study, which will randomize approximately 717 adults with diabetic neuropathic pain at up to 80 sites in the US. NeuroBo also plans to launch a second pivotal Phase III study globally for NB-01 with a similar design in mid-2020.

The primary endpoint for both studies is change from baseline to week 12 of the weekly mean of daily pain scores (an 11-point Pain Intensity Numerical Rating Score, PI-NRS), using an electronic patient diary.

The key secondary endpoint is the number of responders on the Patient Global Impression of Change Scale (PGIS), defined as “much improved” or “very much improved”. NeuroBo plans to conduct an interim analysis of results during the first half of 2020, and expects to complete the study mid-2021.

In addition to pain alleviation, preclinical work on NB-01 has demonstrated effects on increasing the release of nerve growth factor (NGF), stimulating nerve growth, and inhibiting advanced glycation end-products (AGEs) and inflammatory markers.

“While our initial objective is to confirm the Phase 2 results on pain improvement, we believe that NB-01 has a strong potential to be a disease-modifying therapy, and we hope to differentiate our drug from other pain treatments with additional biomarker work to monitor and assess disease progression.”

NeuroBo’s second candidate, NB-02, is an IND-ready neuroprotective drug that targets Alzheimer’s Disease. In preclinical studies, NB-02 has demonstrated inhibition of amyloid beta (Aβ) deposition and of tau-phosphorylation, as well as reduction of acetylcholinesterase activity and decrease of inflammatory markers.

Recent work on NB-02 was presented at the Society for Neuroscience annual meeting in a session titled “Alzheimer’s Disease and Other Dementias: Therapeutic Strategies: Preclinical Cellular Models” by a research group from Massachusetts General Hospital and Harvard Medical School. This group previously reported that NB-02 arrested amyloid plaque deposition and decreased the number of neurons with elevated intracellular calcium levels in a genetic mouse model.

Their recent studies showed that NB-02 prevents the increase in calcium overload in primary neurons and astrocytes caused by amyloid-β oligomers. The group concluded that NB-02 has great promise as a potential therapeutic for Alzheimer’s disease. Additional work is being planned to characterize the multi-mechanistic effects of the drug and to design a Phase IIa clinical trial in mild to moderate stages of the disease.